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OpenTrials
Completed

NCT Number: NCT03247881

Pilot Study on Mixed Nuts and Food Intake

The objectives of this study are 1) to determine if consumption of mixed nuts influences food intake and choice, and 2) to determine how personality traits affect food choice, including mood, stress, tendency to seek approval, tendency toward food cravings, and approach to food intake control.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

The condition of being overweight or obese has skyrocketed in recent decades, bringing with it many secondary health problems. Therefore, it is important to seek strategies to promote weight loss and to assist in weight maintenance after weight loss. Different diet compositions may have different effects on satiety and thus affect food choice. A pilot study will be conducted to determine if mixed nuts affect food selection and intake. Questionnaires will also be administered to determine if personality characteristics are also influencing food choice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 to 60 Years Old
  • 5 year cancer-free

Exclusion criteria

  • pregnant, lactating, or intending to become pregnant during the study
  • known allergy to study foods, including nuts
  • use of tobacco products
  • history of bariatric surgery or nutrient malabsorption disease or diseases requiring special diet
  • Crohn's disease or diverticulitis
  • suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
  • Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
  • Self report of alcohol or substance abuse within the past 12 months and/or current acute treatment or participation in a rehabilitation program for those problems (long-term participation in Alcoholics Anonymous is not an exclusion)

Treatment and study plan

Nut Free Diet

Other

Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.

Other names: Control Diet

Added Mixed Nuts Diet

Other

Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).

Primary outcomes

  1. Body Mass will be measured

    Time frame: Day 0, prior to beginning the diet, day 8, day 29, and day 60

    To track the change in body mass, subjects will be weighed on a scale.

Secondary outcomes

  1. Questionnaires will be administered

    Time frame: Once during the study, no specific time.

    Questionnaires addressing control of eating, eating attitude, social approval, and social desirability will be administered.

  2. Mood questionnaire will be administered

    Time frame: Day 0, Day 8, and Day 29.

    A mood questionnaire will be administered.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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